Pregnancy Complications from Herceptin, PERJETA, and KADCYLA

Contact Us to Start Enrollment

Disclaimer

Thank you for submitting your email information.

A registry representative will be in touch with you to finalize enrollment details and respond to any question you may have.

Do I Need Authorization From My Patients ?

Do I Need Authorization From My Patients ?

This registry was required by the FDA and is exempt from HIPAA authorization requirements. Under 45 Code of Federal Regulations (CFR)-164.512(b)(1)(iii) of the HIPAA regulations, an authorization is not required for disclosure of health information for purposes related to the quality, safety, or effectiveness of an FDA-regulated therapy. This regulation applies to the MotHER Pregnancy Registry.

Informed consent (either verbal or written) is required. Healthcare professionals will not be able to enroll their patients without informed consent being obtained. They are allowed to review the ICF with their patients and then submit the signed document. The registry also requires medical releases to be able to contact any healthcare professional.

Need to fax forms to the registry?

Fax the registry at 1-800-800-1052.